A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT02362503Tipo: INTERVENTIONALInicio: 23 de feb de 2015Fin estimado: 30 de sept de 2026

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men and non-pregnant women with chronic HIV-1 infection
Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes
Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)
Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety
Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort
Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort

Criterios de exclusión

Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)
HIV-2 infection
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 7 x ULN
Alkaline Phosphatase \> 5 x ULN
Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)

Intervenciones

drug

BMS-663068

other

Placebo

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Rosario, Argentina

Patrocinadores

PrincipalViiV Healthcare

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